Identity
- Trade Name
- MDT Diamond Coated Dental Burs EUDAMED
- Device Name
- Sterile Diamond Coated Dental Burs EUDAMED
- Model / Reference
- 117112-44-8M EUDAMED
Identifiers
- Primary DI / UDI-DI
- 67291046388688 EUDAMED
- Basic UDI-DI
- 7291046DiamondSterileFM EUDAMED
- EMDN Code
- Q010501 DENTAL BURS AND ABRASIVE DISKS, SINGLE-USE EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Italy EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Category: Carbide dental bur, single-use
MDT Diamond Coated Dental Burs by MDT Micro Diamond Technologies Ltd. — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Carbide dental bur, single-use.
- SSW CARBIDE — SS White Burs LLC · Class I
- CYBERTECH — CB Healthcare Consulting GmbH · Class IIa
- SSW CARBIDE GREAT WHITE — SS White Burs LLC · Class I
- DIAMOND BUR 1015C - Box with 10 — 3R Indústria E Comércio LTDA · Class I
- MAXCUT CARBIDE BUR (10/pk) FG 171 — SCOTT'S DENTAL SUPPLY L.L.C. · Class I
- Trephine Drill 4.4/5.2mm — Nobel Biocare AB · Class IIa
- SSW CARBIDE GREAT WHITE — SS White Burs LLC · Class I
- SSW CARBIDE — SS White Burs LLC · Class I
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 7291046DiamondSterileFM | Class IIa | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- MDT Micro Diamond Technologies Ltd.
- EUDAMED SRN
- IL-MF-000008464
- Authorised Representative
- Obelis s.a. BE-AR-000000106
Sources (1)
- EUDAMED 32510b77-8450-4e43-9d5b-7cc337e994ac 61 fields · synced May 22, 2026